Announcement of the Re-Approval of AABB (Association for the Advancement of Blood and Biotherapies) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988, 31755-31757 [2024-08809]
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Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Notices
Supporting Regulations in 42 CFR
433.68 through 433.74; Use: States may
elect to submit a waiver to CMS for the
broad based and/or uniformity
requirements for any health care related
tax program which does not conform to
the broad based and uniformity
requirements. It is also the
responsibility of each State to
demonstrate that their tax program(s) do
not violate the hold harmless provision.
For a waiver to be approved and a
determination that the hold harmless
provision is not violated, States must
submit written documentation which
satisfies the regulatory requirements.
Without this information, the amount of
FFP (Federal financial participation)
payable to a State cannot be correctly
determined. Form Number: CMS–R–148
(OMB control number: 0938–0618);
Frequency: Quarterly and occasionally;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
50; Total Annual Responses: 40; Total
Annual Hours: 3,200. (For policy
questions regarding this collection
contact Stuart Goldstein at 410–786–
0694.)
5. Title of Information Collection:
Pharmacy Benefit Manager
Transparency for Qualified Health
Plans; Type of Information Collection
Request: Revision of a currently
approved collection; Use:
Implementation of section 1150A of the
Social Security Act, as added by section
6005 of the Patient Protection and
Affordable Care Act (ACA), requires,
among other entities, Qualified Health
Plans (QHPs) and pharmacy benefit
managers (PBMs) that serve QHP issuers
to report information on prescription
drug benefits to the U.S. Department of
Health and Human Services (HHS).
PBMs are third-party administrators of
prescription programs for a variety of
types of health plans, including QHPs.
CMS finalized regulations for this
reporting at 45 CFR 156.295 and 184.50.
Under these requirements a QHP
issuer is required to report issuer and
plan level prescription drug data to
CMS only when the QHP issuer does
not contract with a PBM to administer
the prescription drug benefit for their
QHPs. Section 1150A(a)(1) of the Social
Security Act authorizes CMS to collect
the same prescription drug and rebate
information from Prescription Drug Plan
sponsors of a prescription drug plan and
Medicare Advantage organizations
offering a Medicare Advantage
Prescription Drug Plan under part D of
title XVIII. Since 2012, CMS has
collected these data from Part D
sponsors as part of the Medicare Part D
Direct and Indirect Remuneration (DIR)
reporting requirement, and detailed
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drug information for each National Drug
Code (NDC) from the Prescription Drug
Event (PDE) data that plans are required
to submit.
CMS is formally requesting an
extension of this ICR in connection with
submission from QHP issuers that do
not contract with a PBM and PBMs
(hereinafter referred to as ‘‘submitters’’).
The information required from
submitters and the process of
submission has changed since the
previous OMB approval. The submitters
are now required to complete a web
form that reports the allocation
methodology that is selected by the
submitters to allocate data, where
necessary. Submitters are required to
maintain internal documentation of the
allocation methodologies chosen, as
CMS may need to follow up with the
submitters to better understand the
methodology. The associated burden
estimates for this collection reflect the
time and effort for submitters to provide
prescription drug benefit information to
CMS using the Health Information
Oversight System (HIOS) module. Form
Number: CMS–10725 (OMB control
number: 0938–1394); Frequency:
Annually; Affected Public: Private
Sector, Business or other For-Profits;
Number of Respondents: 278; Number
of Responses: 278; Total Annual Hours:
1,285. (For questions regarding this
collection, contact LeAnn Brodhead at
(301) 492–4493.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–08828 Filed 4–24–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3449–N]
Announcement of the Re-Approval of
AABB (Association for the
Advancement of Blood and
Biotherapies) as an Accreditation
Organization Under the Clinical
Laboratory Improvement Amendments
of 1988
Centers for Medicare &
Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Notice.
AGENCY:
This notice announces the
application of the Association for the
Advancement of Blood and Biotherapies
(AABB) for re-approval as an
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
31755
accreditation organization for clinical
laboratories under the Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) program. This deeming
authority is granted to AABB for the
Blood Bank and Transfusion Service
(BB/TS) program, the
Immunohematology Reference
Laboratory (IRL) program, the Molecular
Testing (MT) program, and the Cellular
Therapy (CT) program. We have
determined that AABB meets or exceeds
the applicable CLIA requirements. We
are announcing the re-approval and
grant AABB deeming authority for a
period of 6 years.
DATES: The approval is effective from
April 25, 2024 to April 25, 2030.
FOR FURTHER INFORMATION CONTACT:
Daralyn Hassan, 410–786–9360.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative
Authority
On October 31, 1988, the Congress
enacted the Clinical Laboratory
Improvement Amendments of 1988
(CLIA) (Pub. L. 100–578). CLIA
amended section 353 of the Public
Health Service Act. We issued a final
rule implementing the accreditation
provisions of CLIA on July 31, 1992 (57
FR 33992). Under those provisions, we
may grant deeming authority to an
accreditation organization if its
requirements for laboratories accredited
under its program are equal to or more
stringent than the applicable CLIA
program requirements in 42 CFR part
493 (Laboratory Requirements). Subpart
E of part 493 (Accreditation by a Private,
Nonprofit Accreditation Organization or
Exemption Under an Approved State
Laboratory Program) specifies the
requirements an accreditation
organization must meet to be approved
by CMS as an accreditation organization
under CLIA.
II. Notice of Re-Approval of AABB as
an Accreditation Organization
In this notice, we approve the
Association for the Advancement of
Blood and Biotherapies (AABB) as an
organization that may accredit
laboratories for purposes of establishing
their compliance with CLIA
requirements for the following specialty
and subspecialty areas under CLIA:
• Microbiology, including
Bacteriology, Mycology, Parasitology,
and Virology.
• Diagnostic Immunology, including
Syphilis Serology and General
Immunology.
• Chemistry, including Routine
Chemistry.
• Hematology.
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Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Notices
lotter on DSK11XQN23PROD with NOTICES1
• Immunohematology, including
ABO Group & Rh Group, Antibody
Detection, Antibody Identification, and
Compatibility Testing.
We have examined the initial AABB
application and all subsequent
submissions to determine its
accreditation program’s equivalency
with the requirements for re-approval of
an accreditation organization under
subpart E of part 493. We have
determined that AABB meets or exceeds
the applicable CLIA requirements. We
have also determined that AABB will
ensure that its accredited laboratories
will meet or exceed the applicable
requirements in subparts H, I, J, K, M,
Q, and the applicable sections of R.
Therefore, we grant AABB re-approval
as an accreditation organization under
subpart E of part 493, for the period
stated in the DATES section of this notice
for the submitted specialty and
subspecialty areas under CLIA. As a
result of this determination, any
laboratory that is accredited by AABB
during the time period stated in the
DATES section of this notice will be
deemed to meet the CLIA requirements
for the listed specialties and
subspecialties, and therefore, will
generally not be subject to routine
inspections by a State survey agency to
determine its compliance with CLIA
requirements. The accredited laboratory,
however, is subject to validation and
complaint investigation surveys
performed by CMS or its agent(s).
III. Evaluation of AABB Request for ReApproval as an Accreditation
Organization Under CLIA
The following describes the process
we used to determine that the AABB
accreditation program meets the
necessary requirements to be approved
by CMS and that, as such, we may
approve AABB as an accreditation
program with deeming authority under
the CLIA program. AABB formally
applied to CMS for re-approval as an
accreditation organization under CLIA
for the following specialties and
subspecialties:
• Microbiology, including
Bacteriology, Mycology, Parasitology,
and Virology.
• Diagnostic Immunology, including
Syphilis Serology and General
Immunology.
• Chemistry, including Routine
Chemistry.
• Hematology.
• Immunohematology, including
ABO Group & Rh Group, Antibody
Detection, Antibody Identification, and
Compatibility Testing.
In reviewing these materials, we
reached the following determinations
VerDate Sep<11>2014
18:54 Apr 24, 2024
Jkt 262001
for each applicable part of the CLIA
regulations:
A. Subpart E—Accreditation by a
Private, Nonprofit Accreditation
Organization or Exemption Under an
Approved State Laboratory Program
AABB submitted a description of its
mechanism for monitoring compliance
with all requirements equivalent to
condition-level requirements, a list of
all its current laboratories and the
expiration date of their accreditation,
and a detailed comparison of the
individual accreditation requirements
with the comparable condition-level
requirements. We have determined that
AABB’s policies and procedures for
oversight of laboratories performing
laboratory testing for the submitted
CLIA specialties and subspecialties are
equivalent to those required by our
CLIA regulations with respect to
inspection, monitoring proficiency
testing (PT) performance, investigating
complaints, and making PT information
available. AABB also submitted
documentation regarding its
requirements for monitoring and
inspecting laboratories and describing
its own standards regarding
accreditation organization data
management, inspection processes,
procedures for removal or withdrawal of
accreditation, notification requirements,
and accreditation organization
resources. The requirements of the
accreditation programs submitted for reapproval are equal to or more stringent
than the requirements of the CLIA
regulations.
B. Subpart H—Participation in
Proficiency Testing for Laboratories
Performing Nonwaived Testing
AABB’s requirements are equal to or
more stringent than the CLIA
requirements at §§ 493.801 through
493.865. Like CLIA, all AABB’s
accredited laboratories are required to
participate in an HHS-approved PT
program for tests listed in part 493
subpart I. Additionally, AABB
administers a non-regulated PT program
to challenge the ability of the
laboratories in the IRL program to
resolve complex serological problems.
Laboratories in the MT program are
required to participate in a graded PT
program or a sample exchange program.
C. Subpart J—Facility Administration
for Nonwaived Testing
We have determined that AABB
requirements are equal to the CLIA
requirements at §§ 493.1100 through
493.1105.
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Fmt 4703
Sfmt 4703
D. Subpart K—Quality System for
Nonwaived Testing
We have determined that AABB
requirements are equal to the CLIA
requirements at §§ 493.1200 through
493.1299.
E. Subpart M—Personnel for Nonwaived
Testing
We have determined that AABB
requirements are equal to the CLIA
requirements at §§ 493.1403 through
493.1495 for laboratories that perform
moderate and high complexity testing.
F. Subpart Q—Inspection
We have determined that AABB
requirements are equal to the CLIA
requirements at §§ 493.1771 through
493.1780. AABB will continue to
conduct biennial onsite inspections.
G. Subpart R—Enforcement Procedures
AABB meets the requirements of
subpart R to the extent that it applies to
accreditation organizations. AABB
policy sets forth the actions the
organization takes when laboratories it
accredits do not comply with its
requirements and standards for
accreditation. When appropriate, AABB
will deny, suspend, or revoke
accreditation in a laboratory accredited
by AABB and report that action to us
within 30 days. AABB also provides an
appeals process for laboratories that
have had accreditation denied,
suspended, or revoked.
We have determined that AABB
laboratory enforcement and appeal
policies are equal to or more stringent
than the requirements of part 493
subpart R as they apply to accreditation
organizations.
IV. Federal Validation Inspections and
Continuing Oversight
In accordance with § 493.563, the
Federal validation inspections of
laboratories accredited by AABB may be
conducted on a representative sample
basis or in response to substantial
allegations of noncompliance (that is,
complaint inspections). The outcome of
those validation inspections, performed
by CMS or our agents, or the State
survey agencies, will be our principal
means for verifying that the laboratories
accredited by AABB remain in
compliance with CLIA requirements.
This Federal monitoring is an ongoing
process.
V. Removal of Re-Approval as an
Accrediting Organization
CLIA regulation at § 493.575 provide
that we may rescind the approval of an
accreditation organization, such as that
of AABB, for cause, before the end of
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Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Notices
the effective date of re-approval. If we
determine that AABB has failed to
adopt, maintain, and enforce
requirements that are equal to, or more
stringent than, the CLIA requirements or
that systemic problems exist in its
monitoring, inspection, or enforcement
processes, we may impose a
probationary period, not to exceed 1
year, in which AABB would be allowed
to address any identified issues. Should
AABB be unable to address the
identified issues within that timeframe,
we may, in accordance with the
applicable regulations, revoke AABB’s
deeming authority under CLIA.
Should circumstances result in our
withdrawal of AABB’s re-approval, we
will publish a notice in the Federal
Register explaining the basis for
removing its re-approval.
VI. Collection of Information
Requirements
The information collection
requirements associated with the
accreditation process for clinical
laboratories under the CLIA program are
currently OMB-approved under OMB
control number 0938–0686 and expire
May 31, 2025. Additionally, this notice
does not impose any new or revised
information collection requirements,
that is, reporting, recordkeeping, or
third-party disclosure requirements.
Consequently, it does not need to be
reviewed by the Office of Management
and Budget (OMB) under the authority
of the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq).
VII. Executive Order 12866 Statement
lotter on DSK11XQN23PROD with NOTICES1
In accordance with the provisions of
Executive Order 12866, this notice was
not reviewed by the Office of
Management and Budget.
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Chiquita Brooks-LaSure, having
reviewed and approved this document,
authorizes Trenesha Fultz-Mimms, who
is the Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Trenesha Fultz-Mimms,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2024–08809 Filed 4–24–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–5473]
Promotional Labeling and Advertising
Considerations for Prescription
Biological Reference Products,
Biosimilar Products, and
Interchangeable Biosimilar Products:
Questions and Answers; Revised Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a revised
draft guidance for industry entitled
‘‘Promotional Labeling and Advertising
Considerations for Prescription
Biological Reference Products,
Biosimilar Products, and
Interchangeable Biosimilar Products:
Questions and Answers.’’ FDA is
issuing this revised draft guidance to
address questions that manufacturers,
packers, distributors, and their
representatives (firms) may have when
developing FDA-regulated promotional
labeling and advertisements
(promotional communications) for
prescription reference products,
biosimilar products, and
interchangeable biosimilar products
licensed under the Public Health
Service Act (PHS Act). In conjunction
with the enactment of the Biosimilar
User Fee Amendments of 2022 (BsUFA
III), FDA agreed to publish a draft
guidance on promotional labeling and
advertising considerations for
interchangeable biosimilar products, as
described in the document titled
‘‘Biosimilar Biological Product
Reauthorization Performance Goals and
Procedures Fiscal Years 2023 through
2027.’’ The revised draft guidance is
consistent with this commitment and
replaces the draft guidance for industry
entitled ‘‘Promotional Labeling and
Advertising Considerations for
Prescription Biological Reference and
Biosimilar Products: Questions and
Answers’’ issued on February 4, 2020.
SUMMARY:
Submit either electronic or
written comments on the draft guidance
by June 24, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
DATES:
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
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18:54 Apr 24, 2024
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31757
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–5473 for ‘‘Promotional Labeling
and Advertising Considerations for
Prescription Biological Reference
Products, Biosimilar Products, and
Interchangeable Biosimilar Products:
Questions and Answers.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
E:\FR\FM\25APN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 81 (Thursday, April 25, 2024)]
[Notices]
[Pages 31755-31757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08809]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3449-N]
Announcement of the Re-Approval of AABB (Association for the
Advancement of Blood and Biotherapies) as an Accreditation Organization
Under the Clinical Laboratory Improvement Amendments of 1988
AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the application of the Association for
the Advancement of Blood and Biotherapies (AABB) for re-approval as an
accreditation organization for clinical laboratories under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA) program. This deeming
authority is granted to AABB for the Blood Bank and Transfusion Service
(BB/TS) program, the Immunohematology Reference Laboratory (IRL)
program, the Molecular Testing (MT) program, and the Cellular Therapy
(CT) program. We have determined that AABB meets or exceeds the
applicable CLIA requirements. We are announcing the re-approval and
grant AABB deeming authority for a period of 6 years.
DATES: The approval is effective from April 25, 2024 to April 25, 2030.
FOR FURTHER INFORMATION CONTACT: Daralyn Hassan, 410-786-9360.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative Authority
On October 31, 1988, the Congress enacted the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) (Pub. L. 100-578). CLIA amended
section 353 of the Public Health Service Act. We issued a final rule
implementing the accreditation provisions of CLIA on July 31, 1992 (57
FR 33992). Under those provisions, we may grant deeming authority to an
accreditation organization if its requirements for laboratories
accredited under its program are equal to or more stringent than the
applicable CLIA program requirements in 42 CFR part 493 (Laboratory
Requirements). Subpart E of part 493 (Accreditation by a Private,
Nonprofit Accreditation Organization or Exemption Under an Approved
State Laboratory Program) specifies the requirements an accreditation
organization must meet to be approved by CMS as an accreditation
organization under CLIA.
II. Notice of Re-Approval of AABB as an Accreditation Organization
In this notice, we approve the Association for the Advancement of
Blood and Biotherapies (AABB) as an organization that may accredit
laboratories for purposes of establishing their compliance with CLIA
requirements for the following specialty and subspecialty areas under
CLIA:
Microbiology, including Bacteriology, Mycology,
Parasitology, and Virology.
Diagnostic Immunology, including Syphilis Serology and
General Immunology.
Chemistry, including Routine Chemistry.
Hematology.
[[Page 31756]]
Immunohematology, including ABO Group & Rh Group, Antibody
Detection, Antibody Identification, and Compatibility Testing.
We have examined the initial AABB application and all subsequent
submissions to determine its accreditation program's equivalency with
the requirements for re-approval of an accreditation organization under
subpart E of part 493. We have determined that AABB meets or exceeds
the applicable CLIA requirements. We have also determined that AABB
will ensure that its accredited laboratories will meet or exceed the
applicable requirements in subparts H, I, J, K, M, Q, and the
applicable sections of R. Therefore, we grant AABB re-approval as an
accreditation organization under subpart E of part 493, for the period
stated in the DATES section of this notice for the submitted specialty
and subspecialty areas under CLIA. As a result of this determination,
any laboratory that is accredited by AABB during the time period stated
in the DATES section of this notice will be deemed to meet the CLIA
requirements for the listed specialties and subspecialties, and
therefore, will generally not be subject to routine inspections by a
State survey agency to determine its compliance with CLIA requirements.
The accredited laboratory, however, is subject to validation and
complaint investigation surveys performed by CMS or its agent(s).
III. Evaluation of AABB Request for Re-Approval as an Accreditation
Organization Under CLIA
The following describes the process we used to determine that the
AABB accreditation program meets the necessary requirements to be
approved by CMS and that, as such, we may approve AABB as an
accreditation program with deeming authority under the CLIA program.
AABB formally applied to CMS for re-approval as an accreditation
organization under CLIA for the following specialties and
subspecialties:
Microbiology, including Bacteriology, Mycology,
Parasitology, and Virology.
Diagnostic Immunology, including Syphilis Serology and
General Immunology.
Chemistry, including Routine Chemistry.
Hematology.
Immunohematology, including ABO Group & Rh Group, Antibody
Detection, Antibody Identification, and Compatibility Testing.
In reviewing these materials, we reached the following
determinations for each applicable part of the CLIA regulations:
A. Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program
AABB submitted a description of its mechanism for monitoring
compliance with all requirements equivalent to condition-level
requirements, a list of all its current laboratories and the expiration
date of their accreditation, and a detailed comparison of the
individual accreditation requirements with the comparable condition-
level requirements. We have determined that AABB's policies and
procedures for oversight of laboratories performing laboratory testing
for the submitted CLIA specialties and subspecialties are equivalent to
those required by our CLIA regulations with respect to inspection,
monitoring proficiency testing (PT) performance, investigating
complaints, and making PT information available. AABB also submitted
documentation regarding its requirements for monitoring and inspecting
laboratories and describing its own standards regarding accreditation
organization data management, inspection processes, procedures for
removal or withdrawal of accreditation, notification requirements, and
accreditation organization resources. The requirements of the
accreditation programs submitted for re-approval are equal to or more
stringent than the requirements of the CLIA regulations.
B. Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
AABB's requirements are equal to or more stringent than the CLIA
requirements at Sec. Sec. 493.801 through 493.865. Like CLIA, all
AABB's accredited laboratories are required to participate in an HHS-
approved PT program for tests listed in part 493 subpart I.
Additionally, AABB administers a non-regulated PT program to challenge
the ability of the laboratories in the IRL program to resolve complex
serological problems. Laboratories in the MT program are required to
participate in a graded PT program or a sample exchange program.
C. Subpart J--Facility Administration for Nonwaived Testing
We have determined that AABB requirements are equal to the CLIA
requirements at Sec. Sec. 493.1100 through 493.1105.
D. Subpart K--Quality System for Nonwaived Testing
We have determined that AABB requirements are equal to the CLIA
requirements at Sec. Sec. 493.1200 through 493.1299.
E. Subpart M--Personnel for Nonwaived Testing
We have determined that AABB requirements are equal to the CLIA
requirements at Sec. Sec. 493.1403 through 493.1495 for laboratories
that perform moderate and high complexity testing.
F. Subpart Q--Inspection
We have determined that AABB requirements are equal to the CLIA
requirements at Sec. Sec. 493.1771 through 493.1780. AABB will
continue to conduct biennial onsite inspections.
G. Subpart R--Enforcement Procedures
AABB meets the requirements of subpart R to the extent that it
applies to accreditation organizations. AABB policy sets forth the
actions the organization takes when laboratories it accredits do not
comply with its requirements and standards for accreditation. When
appropriate, AABB will deny, suspend, or revoke accreditation in a
laboratory accredited by AABB and report that action to us within 30
days. AABB also provides an appeals process for laboratories that have
had accreditation denied, suspended, or revoked.
We have determined that AABB laboratory enforcement and appeal
policies are equal to or more stringent than the requirements of part
493 subpart R as they apply to accreditation organizations.
IV. Federal Validation Inspections and Continuing Oversight
In accordance with Sec. 493.563, the Federal validation
inspections of laboratories accredited by AABB may be conducted on a
representative sample basis or in response to substantial allegations
of noncompliance (that is, complaint inspections). The outcome of those
validation inspections, performed by CMS or our agents, or the State
survey agencies, will be our principal means for verifying that the
laboratories accredited by AABB remain in compliance with CLIA
requirements. This Federal monitoring is an ongoing process.
V. Removal of Re-Approval as an Accrediting Organization
CLIA regulation at Sec. 493.575 provide that we may rescind the
approval of an accreditation organization, such as that of AABB, for
cause, before the end of
[[Page 31757]]
the effective date of re-approval. If we determine that AABB has failed
to adopt, maintain, and enforce requirements that are equal to, or more
stringent than, the CLIA requirements or that systemic problems exist
in its monitoring, inspection, or enforcement processes, we may impose
a probationary period, not to exceed 1 year, in which AABB would be
allowed to address any identified issues. Should AABB be unable to
address the identified issues within that timeframe, we may, in
accordance with the applicable regulations, revoke AABB's deeming
authority under CLIA.
Should circumstances result in our withdrawal of AABB's re-
approval, we will publish a notice in the Federal Register explaining
the basis for removing its re-approval.
VI. Collection of Information Requirements
The information collection requirements associated with the
accreditation process for clinical laboratories under the CLIA program
are currently OMB-approved under OMB control number 0938-0686 and
expire May 31, 2025. Additionally, this notice does not impose any new
or revised information collection requirements, that is, reporting,
recordkeeping, or third-party disclosure requirements. Consequently, it
does not need to be reviewed by the Office of Management and Budget
(OMB) under the authority of the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq).
VII. Executive Order 12866 Statement
In accordance with the provisions of Executive Order 12866, this
notice was not reviewed by the Office of Management and Budget.
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this
document, authorizes Trenesha Fultz-Mimms, who is the Federal Register
Liaison, to electronically sign this document for purposes of
publication in the Federal Register.
Trenesha Fultz-Mimms,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2024-08809 Filed 4-24-24; 8:45 am]
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